A Study to Investigate the Effect of MT-8554 on the Pharmacokinetics of Simvastatin and Rosuvastatin in Healthy Subjects

Healthy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02675309
• Other study ID #: MT-8554-E05
• Status: Completed
• Phase: Phase 1
• First received: February 3, 2016
• Last updated: March 23, 2016
• Start date: February 2016
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effect of MT-8554 on the pharmacokinetics of simvastatin and rosuvastatin in healthy subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy and free from clinically significant illness or disease

• Male Caucasian subjects aged 18 to 55

• A body weight of =60 kg

Exclusion Criteria:

• Participation in more than three clinical studies involving administration of an Investigational Medicinal Product in the previous year, or any study within 12 weeks.

• Clinically significant endocrine, thyroid, hepatic, respiratory, gastro-intestinal, renal, cardiovascular disease, or history of any significant psychiatric/psychotic illness disorder.

• Clinically relevant abnormal medical history, physical findings or laboratory values

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• MT-8554

• rosuvastatin

• simvastatin

Locations

Country	Name	City	State
United Kingdom	Investigational center	City name

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration-time curve (AUC) of rosuvastatin alone and in the presence of MT-8554.		72 hours post dose	No
Primary	Cmax of rosuvastatin alone and in the presence of MT-8554.		72 hours post dose	No
Primary	AUC of simvastatin/simvastatin acid alone and in the presence of MT-8554.		24 hours post dose	No
Primary	Cmax of simvastatin/simvastatin acid alone and in the presence of MT-8554.		24 hours post dose	No
Secondary	Safety and Tolerability as measured by vital signs		Up to Day 16	Yes
Secondary	Safety and Tolerability as measured by number of participants with adverse events		Up to Day 16	Yes